Prestige Ameritech: FDA clearances and approvals
Prestige Ameritech has 6 FDA 510(k) clearances (first 2006, latest 2024), across 4 product codes in 1 review panel. Median 510(k) review time: 190 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 2 | 265 |
| 2017 | 1 | 117 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 449 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Prestige Ameritech's cleared 510(k)s took a median 283 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 141 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FXX | Mask, Surgical | 3 | 3 |
| MSH | Respirator, Surgical | 1 | 1 |
| OUK | Surgical Mask With Antimicrobial/Antiviral Agent | 1 | 1 |
| OXZ | Pediatric/Child Facemask | 1 | 1 |
Review panels
- General Hospital (6)
Most recent Prestige Ameritech 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231741 | ProGear® Surgical Mask with Oxafence®, Model AV82030 | OUK | 2024-09-05 | 449 |
| K171162 | Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield | FXX | 2017-08-15 | 117 |
| K160100 | Prestige Ameritech Pediatric/Childs Face mask | OXZ | 2016-10-07 | 262 |
| K152561 | Communicator Surgical Facemask with Clear Window | FXX | 2016-06-03 | 268 |
| K102092 | PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES | MSH | 2010-10-06 | 71 |
| K061716 | PRESTIGE AMERITECH FACE MASK | FXX | 2006-08-14 | 56 |
Recalls
openFDA lists no recalls under a recalling firm named Prestige Ameritech.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Prestige Ameritech have?
Prestige Ameritech has 6 FDA 510(k) clearances (first 2006, latest 2024), across 4 product codes in 1 review panel.
How long does FDA take to clear Prestige Ameritech's 510(k)s?
The median time from FDA receipt to decision across Prestige Ameritech's cleared 510(k)s is 190 days.
What devices does Prestige Ameritech make?
Its most frequent FDA product codes are FXX (Mask, Surgical, 3); MSH (Respirator, Surgical, 1); OUK (Surgical Mask With Antimicrobial/Antiviral Agent, 1).
Has Prestige Ameritech had device recalls?
openFDA lists no recalls under a recalling firm name matching Prestige Ameritech. Related entities may recall under other names.
Next steps
- See all 6 Prestige Ameritech clearances with predicates and recalls
- Run predicate analysis for product code FXX, Prestige Ameritech's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.